Development of a Pharmacogenomic Panel for Early Detection of Chemotherapy- and Immunotherapy-Induced Cardiotoxicity.

NCT07663357 | Recruiting

• 2 other identifiers: BIPEC408801/2024-7
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 6

Brief Summary

To evaluate the use of a pharmacogenetic and pharmacoepigenetic panel for predicting chemotherapy- and immunotherapy-induced cardiotoxicity in cancer patients.

Conditions

Cardiotoxicity

Keywords

oncology; Cardiotoxicity; pharmacogenomics; epigenomics

Outcome Measures

Primary Outcomes (1)

• Cardiotoxicity

  Throughout treatment and follow-up, cardiotoxicity will be defined according to the criteria established by the 2022 European Society of Cardiology (ESC) Cardio-Oncology Guidelines.

  1 year

Study Arms (4)

Discovery cohort with cardiotoxicity

This cohort will consist of participants with cardiotoxicity after one year of treatment and will be used for exome analysis and miRNA sequencing. In this cohort, metabolomic and proteomic profiling, drug concentration measurements, and assessments of immune function and inflammation will also be be performed.

Validation cohort with cardiotoxicity

This cohort will consist of participants with cardiotoxicity after one year of treatment and will be used to validate the genetic variants identified through exome analysis, as well as the miRNAs selected following sequencing.

Discovery cohort without cardiotoxicity

This cohort will consist of participants without cardiotoxicity after one year of treatment and will be used for exome analysis and miRNA sequencing. In this cohort, metabolomic and proteomic profiling, drug concentration measurements, and assessments of immune function and inflammation will also be be performed.

Validation cohort without cardiotoxicity

This cohort will consist of participants without cardiotoxicity after one year of treatment and will be used to validate the genetic variants identified through exome analysis, as well as the miRNAs selected following sequencing.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A prospective cohort of adult breast cancer patients receiving cardiotoxic cancer therapies, followed for cardiovascular assessment and multi-omics profiling to identify predictors of treatment-related cardiotoxicity.

You may qualify if:

• Patients with a confirmed diagnosis of breast cancer who are scheduled to initiate treatment with anthracyclines and/or HER2-targeted therapies (anti-HER2 therapies).

You may not qualify if:

• Patients with a left ventricular ejection fraction (LVEF) \< 50%;
• Patients who have undergone chemotherapy and/or radiotherapy within the previous year;
• Patients with chronic kidney disease and a glomerular filtration rate (GFR) \< 30 mL/min/1.73 m²;
• Patients with uncontrolled hypertension;
• Patients with complex congenital heart disease.

Sponsors & Collaborators

• Beneficência Portuguesa de São Paulo: lead

Study Sites (6)

Instituto do Câncer do Ceará

Fortaleza, Ceará, 60430-230, Brazil

NOT YET RECRUITING

Complexo Hospitar HUOC/PROCAPE

Recife, Pernambuco, 50100-130, Brazil

NOT YET RECRUITING

Universidade Federal de Santa Catarina

Florianópolis, Santa Catarina, 88040-900, Brazil

NOT YET RECRUITING

Hospital Beneficente UNIMAR

Marília, São Paulo, 17525-160, Brazil

NOT YET RECRUITING

FAMERP - Faculdade de Medicina de São José do Rio Preto

São José do Rio Preto, São Paulo, 15090-000, Brazil

NOT YET RECRUITING

Hospital BP - A Beneficência Portuguesa de São Paulo

São Paulo, São Paulo, 01323-900, Brazil

RECRUITING

MeSH Terms

Conditions

Cardiotoxicity; Neoplasms

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Advisor, Professor, and Principal Investigator

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 23, 2026
• Study Start: May 11, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): December 30, 2029
• Last Updated: June 23, 2026

Record last verified: 2026-06

Locations

BR (6)